Hims & Hers Health Off 11% On FDA Decision
Hims & Hers Health Off 11% On FDA Decision
$Hims & Hers Health (HIMS.US)$ shares are 11% trading lower Thursday. The U.S. Food and Drug Administration issued a new decision about tirzepatide injection shortages. Here's what you need to know.
$Hims & Hers Health (HIMS.US)$ 週四,$HERS$的股票交易下跌11%。美國食品和藥物管理局發佈了關於替爾扎肽注射劑短缺的新決定。您需要知道的是。
What To Know: The FDA announced today that the shortage of tirzepatide injections, a GLP-1 medication, has been resolved. The shortage began in 2022 due to high demand and has ended as manufacturing capacity and product availability are sufficient to meet national demand. However, the FDA warned of potential localized supply chain disruptions as products are distributed to pharmacies.
需要了解的事項:FDA今天宣佈tirzepatide注射劑,這種GLP-1藥物的短缺問題已經解決。短缺始於2022年,主要由於需求量大,而現在製造能力和產品供應足以滿足全國需求。然而,FDA警告在將產品分發到藥房時可能會出現局部供應鏈中斷的情況。
To avoid interruptions in treatment, the FDA is allowing compounders using tirzepatide to continue their activities temporarily. State-licensed pharmacies have until February 18, 2025, and outsourcing facilities until March 19, 2025, to comply with this grace period.
爲了避免治療中斷,FDA允許使用tirzepatide的配藥師暫時繼續其活動。獲得州許可的藥房必須在2025年2月18日之前遵守,而外包設施則需在2025年3月19日之前合規,以享受這一寬限期。
Meanwhile, other GLP-1 drugs, including dulaglutide, semaglutide and liraglutide, remain in shortage. Despite some reports of product availability, the FDA has not yet resolved these shortages and is actively monitoring the situation.
與此同時,其他GLP-1藥物,包括dulaglutide、semaglutide和liraglutide,仍然短缺。儘管有一些產品可用的報告,FDA尚未解決這些短缺,並正在積極監測情況。
This announcement follows the FDA's October 2024 decision that determined that the tirzepatide shortage was over. However, this was reevaluated after legal challenges. This updated decision confirms that the shortage is resolved.
這一聲明是在FDA於2024年10月做出的決定之後,該決定認爲tirzepatide的短缺問題已經結束。然而,在法律挑戰之後,這一決定被重新評估。此次更新的決定確認短缺問題已經解決。
The news may influence investor sentiment, given the role of GLP-1 drugs in weight loss and diabetes treatment. Ongoing shortages of similar medications and regulatory updates could continue to affect market perspectives.
這條資訊可能會影響投資者情緒,因爲GLP-1藥物在減肥和糖尿病治療中的作用。類似藥物的持續短缺和監管更新可能會繼續影響市場前景。